Trevor Lewis

Trevor has provided training of national regulatory authorities and senior officials in European Union (EU) medical device directives, especially in India, China, Egypt and Turkey but also all MEDA countries in behalf of the European Commission (EC) for more than 10 years.

He has provided guidance and advice on medical regulation implementation to Canada, the Republic of Moldova, Hong Kong and China. This has included working with the European Commission and Chinese Government via BSI on the comparison of clinical evaluation in both jurisdictions to inform the European Commission (EC) and Chinese Food and Drug Administration (CFDA) that is reflected in the published MEDDEV 2.7/2 rev2 Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC (September 2015).

Trevor has worked with individual entrepreneurs, small companies, multi-nationals, universities and governments all around the world to help take innovative medical device concepts to market. Naturally quality systems, regulatory affairs and business development are all key to his approach.

Trevor has an in-depth unique mix of technical, financial, business and regulatory skills, which coupled with his experience gained from working in all aspects of medical device innovation have made him a well-known and sought-after professional.

Trevor has experience of large scale international collaboration, he is a former Partner for Exploitation and Regulatory Affairs in TheraEDGE an €8 million EU Framework (FP7) Project; was a consultant to RAPP-ID a €14.7 million Innovative Medicines Initiative (IMI) project – both in molecular diagnostics.

Trevor’s early career was in the Royal Air Force as an Apprentice and Flying Officer before he left to go to Reading University where he read Physics, Electronics and Mathematics. He first worked with medical devices during 1980, whilst still at university, working in the quality assurance department of an electronics company. This work included setting up a patient monitor that was eventually used on Pope John Paul II.

After graduating Trevor worked at Smiths Industries as a Development Engineer working on the Digital Engine Control Unit (DECU) for the Pegasus engine used in the Harrier ‘jump jet’ and various related test equipment used in production of the DECU.

He then became a High Technology Securities Analyst (North American) for stockbrokers Grieveson & Grant – where he met and interviewed some of the great technology entrepreneurs of the 1980s.

He joined Vickers Medical in Basingstoke during 1985 initially as a Design and Development Engineer working on patient monitoring products. He was rapidly promoted to Product Manager and then Marketing Manager working in Hatsboro, PA, USA on neonatal products for global markets. A significant product he helped to create was the ‘Quiet Time’ incubator that was developed out of recognizing the important human factor issues for the baby, parents, nurses and clinicians.

Trevor joined Huntleigh Healthcare in the USA during 1989 and returned to the UK during 1990. He led projects that resulted in Queen’s Awards for Innovation and Export. He was promoted to Director, Corporate and New Business Development for the Group.

After leaving Huntleigh during 1993 he was a Director at Innovation Wales and then General Manager at Ferraris Medical in London.

He was invited to tender for a major national strategic medtech project to work as a consultant for the Welsh Development Agency (WDA) during 1995 and beyond. This led to the founding of the Medical Device Consultancy (MDC). The project objective was to:

“To provide the Welsh Development Agency with the relevant research, strategy, sales arguments, supporting analysis and personal commitment to create a foundation for Wales as a world renown centre of excellence for medical devices.”

The project was a complete success and Trevor went onto provide expert research for the ‘Medical Technologies Cluster Research Project’ for Advantage West Midlands (AWM).

Trevor was a co-founder of the Welsh Medical Technology Forum (1992), now known as MediWales. He provided research, strategy and initial recruitment of members for Medilink West Midlands, plus has assisted most of the Medilinks at some stage during their development. In recent years he has provided training in regulatory affairs, quality systems and product management for both Medilink West Midlands and Medilink East Midlands.

Trevor’s initial regional development consultancy work was concurrently complemented by work in quality systems and regulatory affairs. This was the start of MDC as it is today.

Trevor is particularly pleased that over years several previous clients, initially engaged with at the start-up stage, have grown and developed into successful businesses that have been sold and provided substantial returns for their founders and investors.

Please contact MDC for Trevor’s CV and Training Record if you wish to know more.

Trevor Lewis,Founder, Director andPrincipal Consultant

Trevor is a very experienced consultant in business development and quality systems, with an international reputation in regulatory affairs. He is well known for training medical device regulators around the world.